Kornimate/medical-research-clean huggingface dataset:
evaluation of low blood sugar events in participants with diabetes (mk-0431-402)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (t2dm) who have been treated with sulphonylurea (su) monotherapy or su + metformin (mf) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment. the purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among t2dm participants treated in cardiology, nephrology and family practice settings.


Eligibility criteria:
inclusion criteria * participants diagnosed with type 2 diabetes mellitus (dm). * participants at least 30 years of age at time of type 2 dm diagnosis. * participants treated with su monotherapy or su + mf combination therapy for at least 6 months prior to enrollment. * participants receiving diabetes care from a cardiologist, nephrologist or family practitioner for at least 6 months. * participants with a clinical record in the health care center. * participants in whose medical records a minimum core data set can be found; core data defined as: age, gender, duration of diabetes/age at diagnosis, all glucose-lowering medications (branded and generic names, dosage, dosing frequency, starting and stopping dates) since the start of all antihyperglycemic medications. exclusion criteria * participants with type 1 dm. * participants who are pregnant or with gestational dm. * participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months. * participants requiring daily concomitant usage of insulin. * participants receiving any other oral diabetes medications other than su or su + mf. * participants who are already participating in a clinical trial or other clinical study. * participants for whom it would be impossible to complete the questionnaire.

Keywords: diabetes complications
ultrasound guided axillary brachial plexus block versus supraclavicular block in emergency crushed hand patients

Conditions: the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks

Summary: the current study focused on ultrasound guided brachial plexus block (bpb) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. the brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (scb) and axillary (axb) blocks. aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the scb and axb were done for the two groups respectively. the needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.


Eligibility criteria:
inclusion criteria: * patients with asa physical status ii and iii, and body mass index (bmi) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery exclusion criteria: * patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. also, shocked patients and patients with chronic obstructive airway disease
a feasibility study of senseguard to assess airway responsiveness during methacholine challenge test (mct)

Conditions: Asthma

Summary: senseguard (sg) is an innovative device for respiratory monitoring. at this study sg measurement will be integrated in a methacholine challenge test (mct) for monitoring changes in airway obstruction occurred during mct in parallel to spirometry.

senseguard (sg) is a wireless wearable medical device intended for monitoring of patient's breathing. it allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (rr) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (ti) and expired breath (te). the study goal is to evaluate the capability of sg to measure clinical changes in respiratory parameters. during methacholine challenge test (mct), asthma patients demonstrate airway responsiveness due to airway obstruction. sg will be used to measure respiratory parameters during mct in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed. successful study results will demonstrate the capability of sg to measure changes in airway obstruction leading to future implementation of sg for monitoring of patients with respiratory diseases and improvement of their clinical outcome.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥18. * eligible for mct procedure. the contradictions to mct are listed as exclusion criteria. * provision of a signed and dated informed consent form. * subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the mct: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect. exclusion criteria: * subjects who have known contradictions to mct, including: * tolerate inhalation of the challenge agents * low baseline fev1: airflow limitations in fev1 less than 60% predicted or 1.5l (baseline fev1 of \< 1.5 l or \< 60% predicted). * spirometry quality: inability to consistently reproduce quality spirometry * cardiovascular problems: recent myocardial infarction within past three months, uncontrolled hypertension, known aortic aneurysm * recent ophthalmologic surgery or patients at risk for intracranial pressure elevation. * pregnancy and nursing mothers: methacholine is a pregnancy category c drug and it is not known whether it is excreted in breast milk or is associated with fetal abnormalities. women subjects will be asked to sign a statement, as part of the informe consent form, that they are not pregnant or nursing mothers). * inability to provide informed consent. * known allergic reactions to materials used in the components of the sg, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
study evaluating effexor xr in elderly patients with major depression.

Conditions: Depression

Summary: phase iii study evaluating effexor xr in elderly patients with major depression.


Eligibility criteria:
inclusion criteria: * patients diagnosed with major depression based on dsm-iv-tr * patients having minimal total score of 18 on the ham-d17 and minimal score of 2 on the item of "depressed mood" of ham-d at baseline exclusion criteria: * patients with schizophrenia or any other psychotic disorder * patients with history or presence of bipolar disorder

Keywords: depression
the use of diffuse optical spectroscopy to characterize in response to weight-loss intervention

Conditions: Overweight

Summary: the first step in any clinical intervention against obesity involves sustained lifestyle changes. researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. the researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.

optical technologies under development at the beckman laser institute. diffuse optical spectroscopy imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. it is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. the researcher use diffuse optical spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.

Eligibility criteria:
inclusion criteria: * body mass index greater than 25, overweight * participation in weight loss program exclusion criteria: * a medical history of myocardial infarction or cerebrovascular stroke * pregnancy or planned pregnancy during the course of the study period
the effects of peri-operative pregabalin administration on post-operative analgesia in patients undergoing coronary bypass grafting

Conditions: Postoperative Pain.

Summary: we hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass grafting, and reduces the incidence of opioid-induced side effects such as respiratory depression. this may reduce icu admission and possibly abbreviate length of hospital stay.


Eligibility criteria:
inclusion criteria * patients whom are able and willing to provide written informed consent. * male and female 18-70 years of age. * patients whom are undergoing isolated coronary artery bypass grafting through a midline sternotomy for the treatment of ischemic heart disease. exclusion criteria * patients undergoing cardiac surgery for valvular or pericardial surgery. * patients with a documented ejection fraction of less than 50%. * patients with known chronic renal insufficiency and a calculated creatinine clearance of \< 60ml/min. * patients with known sensitivity to the study drugs. * patients with documented pre-existing chronic pain. * patients with seizure disorders. * patients whom are taking pregabalin or gabapentin * patients on chronic neuroleptic medications for control of psychiatric disorders as to avoid possible drug interactions and to avoid modulation of any pain states by such medications. * patients whom are taking tricyclic antidepressants or serotonin and norepinephrine re-uptake inhibitors(snri) will be excluded because of the effect of these drugs on neuropathic pain. * patients greater than 70 years of age will also be excluded because of their increased risk of side-effects and perioperative confusion. * pregnant or breast feeding females

Keywords: pain. postoperative. cabg.
myocardial infarction and non-contraceptive estrogen use

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Menopause; Postmenopause

Summary: to evaluate whether the use of noncontraceptive estrogen influenced the incidence of first myocardial infarction in women.

background: the use of noncontraceptive estrogens declined after evidence was published that they increase the risk of endometrial cancer. nonetheless, they are still used commonly and for long periods, especially by hysterectomized women. use of the drugs has increased recently, perhaps because the drugs have been recommended as prophylaxis against osteoporosis. the drugs are also being promoted for use in conjunction with a progestin, because it is thought that the combination may protect against endometrial cancer. little is known about the effects of these drug regimens on myocardial infarction risk, and some progestins (in particular the 19-norprogestins) are thought to influence lipid profiles unfavorably. insofar as myocardial infarction is a major cause of morbidity and mortality in women beyond age 49, an effect of these drugs, either beneficial or adverse, on myocardial infarction risk is of considerable public health importance. design narrative: the design was that of a case-control study. cases were selected from women admitted for the first episode of myocardial infarction to any of the participating hospitals in the boston area. for each case, a control was selected from town lists of women living in the same neighborhood as the case and in the same five year age group. cases were interviewed by telephone after discharge from the hospital, and the corresponding control was interviewed within a week or two of the case interview. information was obtained on: the timing and duration of non-contraceptive estrogen use, the names of the preparations and reasons for starting and stopping each episode of use; other drug use particularly oral contraceptives, aspirin, phenylpropanolamine; age at menopause; cigarette smoking; height and weight; histories of previous myocardial infarction, hypertension, pre-eclamptic toxemia, diabetes mellitus, angina pectoris and abnormal serum lipids; reproductive history; alcohol and coffee consumption; personality type based on the framingham type a scale; family history of myocardial infarction; exercise; socioeconomic and life style factors; number of physician visits in last two years and total number of hospital admissions. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the effect of usm-iam-based counselling

Conditions: Diabetes Type 2 on Insulin

Summary: according to the most current local data, the rate of patient's adherence to insulin injections is very low. a recent cross sectional study in klinik pakar perubatan (kpp) hospital universiti sains malaysia (husm) among 355 patients with type 2 diabetes treated with insulin showed only 19% of patients adhered to their insulin regime with the mean fasting plasma glucose of 10mmol/l and mean hba1c of 10.0%. this condition may lead to undesirable health consequences. patients education has been showed to improved adherence. among the 355 participants involved in the study, 82% of the patients have received consultation by diabetic educators yet their glycemic control were suboptimal. a new approaches using a module-based counseling that emphasized on adherence has been developed and the effectiveness of the counseling need to be evaluated.

general objective: to determine the effect of usm-insulin adherence module (u-iam)-based counseling on the insulin adherence, glycemic control and inflammatory markers in poorly-controlled type 2 diabetes mellitus patients on insulin therapy. specific objective: 1. to determine within group changes and between group differences of insulin adherence score (using iaqdm) between patients in intervention and control group at baseline, 3rd month and 6th month 2. to determine within group changes and between group differences of fbs and hba1c between patients in intervention and control group at baseline, 3rd month and 6th month. 3. to determine within group changes and between group differences of hscrp and vcam-1 between patients in intervention and control group at baseline, 3rd month and 6th month. 4. to identify factors associated with nonadherence (before starting of intervention) among patients on insulin such as sociodemographic, smbg and treatment factors.

Eligibility criteria:
inclusion criteria: * age between 18 to 65 years * have been diagnosed with type 2 diabetes mellitus * patients treated with insulin injections for at least 1 year on either basal insulin, basal plus prandial or basal bolus insulin * hba1c between 8 % and 15% exclusion criteria: * do not understand malay language or illiterate * have severe diabetes complications such as chronic kidney disease, heart failure * recurrent hypoglycemia or hypoglycemia unawareness * body mass index (bmi) ≥ 40kg/m2
antiangiogenic peptide vaccine therapy with gemcitabine in treating patient with pancreatic cancer (phase1/2)

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety, and tolerability of hla-a\*2402 restricted epitope peptide vegfr1 and vegfr2 emulsified with montanide isa 51 in combination with gemcitabine

vascular endothelial growth factor receptor 1 and 2 (vegfr1 andvegfr2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and in vivo. according to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with montanide isa 51 in combination with gemcitabine

Eligibility criteria:
inclusion criteria: disease characteristics 1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. measurable disease by ct scan patients characteristics 1. ecog performance status 0-2 2. life expectancy \> 3 months 3. laboratory values as follows: * 2,000/mm3 \< wbc \< 15000/mm3 * platelet count ≥ 750,000/mm³ * total bilirubin ≤ 1.5 x * aspartate transaminase \< 150 iu/l * alanine transaminase \< 150 iu/l * creatinine ≤ 3.0 mg/dl 4. hla-a\*2402 5. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breast-feeder 3. active or uncontrolled infection 4. prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks 5. serious or uncured wound 6. active or uncontrolled other malignancy 7. steroids or immunosuppressing agent dependent status 8. interstitial pneumonia 9. ileus 10. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: epitope peptide ctl pancreatic cancer vaccination vegfr1 vegfr2
a phase 2 study of cdx-0159 in patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (cdx-0159) in patients with chronic spontaneous urticaria

the purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with chronic spontaneous urticaria. there is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (placebo-controlled treatment phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.

Eligibility criteria:
key inclusion criteria: 1. males and females, \>/= 18 years of age. 2. diagnosis of chronic spontaneous urticaria (csu) \>/= 6 months. 3. diagnosis of csu despite the use of a stable regimen of second generation non-sedating h1-antihistamine as defined by: 1. the presence of hives for \>/= 6 weeks at any time prior to visit 1 despite the use of h1-antihistamines. 2. must be on a stable regimen of second generation non-sedating h1-antihistamine for \>/= 4 weeks prior to study treatment. 3. uas7 of \>/= 16 and iss7 of \>/= 8 during the 7 days prior to treatment. 4. normal blood counts and liver function tests 5. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. 6. willing and able to complete a daily symptom electronic diary and comply with study visits. key exclusion criteria: 1. women who are pregnant or nursing. 2. clearly defined cause for chronic urticaria. 3. active, pruritic skin condition in addition to csu. 4. medical condition that would cause additional risk or interfere with study procedures. 5. known active hiv, hepatitis b or hepatitis c infection. 6. vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). inactivated vaccines are allowed such as seasonal influenza injection or covid-19 vaccine. 7. history of anaphylaxis 8. prior treatment with barzolvolimab there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159 barzolvolimab
validation of new g6pd point of care tests against gold standard quantitative

Conditions: Validation; Biosensors; Genotyping

Summary: this is a laboratory research to evaluate performances of quantitative poc g6pd tests (biosensors) against gold standard quantitative laboratory based tests and genotyping.

radical cure of p. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative g6pd tests. different regimens of drug might be more appropriate in subjects with intermediate g6pd activity which can be currently measured only in well equipped laboratories. validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against plasmodium vivax. this study will evaluate performances of quantitative poc g6pd tests (biosensors) against gold standard quantitative laboratory based tests and genotyping. patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 g6pd-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 g6pd-heterozygous women with intermediate activity, and approximately 50 g6pd-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. the home visitor will explain study details and invite to participate in the study. if the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care. after signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. the blood from capillary sample will be used to assess g6pd activity using the poc tests, cbc and laboratory based quantitative tests. the venous blood will be used for reference standard quantitative g6pd assays, hb typing analysis, cbc and buffy-coat will be stored for dna extraction for g6pd genotyping only; leftover blood will be discarded.

Eligibility criteria:
inclusion criteria: * subjects with age ≥ 18 years * subjects willing to participate and sign informed consent form * male and female * previously tested g6pd deficient, g6pd normal and g6pd intermediate or heterozygous for g6pd variants at smru clinic exclusion criteria: * patients with severe malaria or other severe or any acute illness * patients who received a blood transfusion in the last 3 months * patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction) * patients who have not had a critical illness or received other hemolytic drugs (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)